Pulmonary Arterial Hypertension
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-12-12FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for OPSUMIT (macitentan) by Actelion Pharmaceuticals US, Inc., regarding an updated/expanded app…
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FDA approval · 2024-12-12FDA Approved: SILDENAFIL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approves Teva's supplemental application for sildenafil, resulting in approval of a generic sildenafil product.
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EMA approval · 2024-10-25EMA Authorised: Tracleer (bosentan (as monohydrate)) — Janssen-Cilag International N.V.
The European Medicines Agency authorised Tracleer (bosentan) for systemic sclerosis and for pulmonary arterial hypertension.
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EMA approval · 2024-10-24EMA Authorised: Stayveer (bosentan (as monohydrate)) — Janssen-Cilag International NV
The EMA authorised Stayveer (bosentan) for use in pulmonary arterial hypertension and systemic sclerosis (scleroderma) in the European Union…
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FDA approval · 2024-09-17FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for TRACLEER (bosentan) from Actelion Pharmaceuticals US, Inc.
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FDA approval · 2024-09-17FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for Tracleer (bosentan) submitted by Actelion Pharmaceuticals US, Inc., authorizing changes to t…
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FDA approval · 2024-09-17FDA Approved: BOSENTAN — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for bosentan filed by Actavis Pharma, Inc. to authorize the continued marketing of the generic produ…
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FDA approval · 2024-09-17FDA Approved: BOSENTAN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Bosentan from Zydus Pharmaceuticals USA Inc. under ANDA207760. This confirms continued regulator…
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FDA approval · 2024-09-17FDA Approved: BOSENTAN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for BOSENTAN from Sun Pharmaceutical Industries, enabling the generic bosentan to be marketed in the…
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FDA approval · 2024-08-19FDA Approved: AMBRISENTAN — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Ambrisentan from Mylan Pharmaceuticals Inc., approving a generic version of the drug used to tre…
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FDA approval · 2024-08-19FDA Approved: AMBRISENTAN — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for Ambrisentan submitted by Apotex Corp., marking an additional regulatory action for this medicati…
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FDA approval · 2024-08-19FDA Approved: AMBRISENTAN — Supplemental Application (Cipla USA Inc.)
FDA approved Cipla USA Inc.'s supplemental application for ambrisentan (ANDA 210715).
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FDA approval · 2024-08-19FDA Approved: AMBRISENTAN — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for ambrisentan submitted by Zydus Lifesciences Limited. The drug is used to treat pulmonary arteria…
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FDA approval · 2024-08-19FDA Approved: AMBRISENTAN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries' supplemental application to market a generic version of ambrisentan for pulmonary arterial hyper…
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FDA approval · 2024-08-19FDA Approved: AMBRISENTAN — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for ambrisentan from Actavis Pharma, Inc., updating the drug's labeling/approved uses under ANDA…
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FDA approval · 2024-08-19FDA Approved: AMBRISENTAN — Supplemental Application (Sigmapharm Laboratories, LLC)
FDA approved a supplemental application for ambrisentan by Sigmapharm Laboratories to market a generic version of the drug.
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FDA approval · 2024-08-19FDA Approved: AMBRISENTAN — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Ambrisentan from Aurobindo Pharma Limited, enabling the generic form of the drug to be marke…
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FDA approval · 2024-07-08FDA Approved: SILDENAFIL — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a supplemental application for sildenafil citrate (ANI Pharmaceuticals, Inc.) under an approved ANDA.
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EMA approval · 2024-06-28Positive CHMP opinion on first-in-class medicine to treat pulmonary arterial hypertension
The European Medicines Agency's CHMP issued a positive opinion for Winrevair, a first-in-class medicine for pulmonary arterial hypertension,…
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FDA approval · 2024-06-12FDA Approved: EPOPROSTENOL — Original Application (Mylan Institutional LLC)
FDA approved the generic epoprostenol injection from Mylan Institutional LLC under an Original Application; epoprostenol is used to treat pu…
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FDA approval · 2024-04-11FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for OPSUMIT (macitentan) submitted by Actelion Pharmaceuticals US, Inc.
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FDA approval · 2024-03-22FDA Approved: OPSYNVI — Original Application (Actelion Pharmaceuticals US, Inc.)
FDA approved OPSYNVI, a fixed-dose combination of macitentan and tadalafil, under Original Application NDA218490 for pulmonary arterial hype…
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FDA approval · 2024-03-19FDA Approved: TRYVIO — Original Application (Idorsia Pharmaceuticals Ltd)
FDA approves TRYVIO (aprocitentan) from Idorsia in an Original Application (NDA217686) for the treatment of pulmonary arterial hypertension.
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FDA approval · 2024-03-14FDA Approved: TREPROSTINIL — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for TREPROSTINIL water solution from Sandoz Inc, approving a new formulation of treprostinil.
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FDA approval · 2024-02-13FDA Approved: AURLUMYN — Original Application (BTG International Inc)
FDA approved AURLUMYN (iloprost) through an original NDA from BTG International Inc. The approval establishes a new iloprost product for its…